CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
Placebo oral capsule +3 moredrug
Likely dose
12.5 mg hydrochlorothiazidefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03057431
NCT03057431Phase 3Completed

Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis

Insel Gruppe AG, University Hospital Bern·interventional·Posted Feb 20, 2017·Updated Feb 1, 2024

In Brief

A Phase 3 clinical trial evaluating Placebo oral capsule, 12.5 mg hydrochlorothiazide, and 2 other interventions for Nephrolithiasis. Completed, enrolled 416 participants across 12 sites.

Detailed Summary

The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the recurrence prevention of calcium-containing kidney stones. More specifically, the investigators aim to assess the dose-response relationship for three different dosages of HCTZ. Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines. Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrolithiasis
CountriesSwitzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 20, 2017
Enrollment StartMar 9, 2017
Primary CompletionDec 3, 2021
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.4 years ago

Interventions

Placebo oral capsuledrug

Once daily for 3 years

12.5 mg hydrochlorothiazidedrug

Once daily for 3 years

25.0 mg hydrochlorothiazidedrug

Once daily for 3 years

50.0 mg hydrochlorothiazidedrug

Once daily for 3 years